Tech, Operations

Job Description

JOB PURPOSE

• Perform manufacturing operations per production schedule in compliance with cGMP and achieve the operational objectives.

• Meet Site's safety, health and environmental (SHE) performance objectives through compliance with site SHE rules.

• Ability to carry out basic shopfloor trouble shooting, initiate escalation and RTPS, and participate in solution development and implementation.

MAIN RESPONSBILITIES

Manufacturing Excellence

Routine Operation

• Tablet Manufacturing Process - Dispensing, Granulation, Charging, Blending, Compression and Film Coating.
• Perform and maintain Operation Area and Facility housekeeping to meet audit readiness requirement.
• Complete all assigned tasks/activities with accurate documentation.
• Meet performance metrics of the assigned tasks/operations.
• Provides accurate information to report, visual factory and boards.
• Effective communication during shift handover/takeover.
• Conduct On-The-Job training for peer as assigned/required.

Non-Routine Operation I Campaign Turnaround Activities

• Performs equipment cleaning/maintenance/calibration/performance check and setup (at least either two modules) in Tablet Manufacturing Operation and supports equipment cleaning for all operations.
• Responsible to perform and support IQ/OQ/PQ when assigned.

Incident, Deviation Investigation

• Provide detailed information for all events to assist in investigation.
• Responsible to carry out basic shopfloor trouble shooting and escalate to next appropriate level when required.
• Support data collection to assist investigations.

Continuous Improvement

• Participates and supports Kaizen events in operations in accordance with Kaizen plans when assigned.
• Provide improvement feedback based on understanding of lean tools and techniques.

Quality/ SHE Stewardship

Quality

• Ensures manufacturing related activity is completed according to established procedures and all associated documentation is completed as per GMP/GDP standard.

Safety, Health & Environment

• Ensures compliance to all Safety requirements and participates as ERT or DFAT team member when assigned.
• Participates and supports the implementation of actions for Incident Investigations or Audits.
• Highlights "Near Miss”, “Un-safe Condition” and other improvement ideas for work environment.

People Excellence

People Management

• Use Tier process, handover/takeover and other opportunities to engage positively with peers with positive and effective communication to promote teamwork.
• Share technical knowledge and Tap-in to peer as when training / opportunity occurs.

Self

• Exhibit a positive attitude and provide constructive feedback & solutions to issues /opportunities in the workplace.
• Responsible to participate in improvement project and actively generate ideas.
• Develops and updates on career path with manager, which is aligned with Performance Management Process.
• Ensures both operational knowledge and technical skills are maintained and compliant against individual training requirements.
• Must be willing to work in 12 hours rotating shift (day/night).

Qualification:

• A Diploma or a Technical school graduate Science/ Engineering with strong background in operation / maintenance in pharmaceutical / chemical manufacturing experience.

Experience:

• 3 to 5 years of operation / maintenance hands-on experience.

Leadership, Professional and Functional Competencies

• Refer to Career Framework Competency Model.

Other Personal Attributes:

• Strong background in operation of pharmaceutical / chemical systems including hands on experience.
• Experience in safety procedures / practices.
• Familiarized with cGMP/DGP working environment.
• Good writing and communication skill.
• Understanding of lean tools and techniques including Work Standards, Kanban, 5S and Visual management.
• Has the capability to train peer on operations, cleaning and housekeeping.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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